Safety, efficacy, and immunogenicity of a live, quadrivalent human-bovine reassortant rotavirus vaccine in healthy infants

• Published in: The Journal of pediatrics 2004-02, Vol.144 (2), p.184-190
• Main Authors: Clark, H.Fred, Bernstein, David I, Dennehy, Penelope H, Offit, Paul, Pichichero, Michael, Treanor, John, Ward, Richard L, Krah, David L, Shaw, Alan, Dallas, Michael J, Laura, Digilio, Eiden, Joseph J, Ivanoff, Nathalie, Kaplan, Karen M, Heaton, Penny
• Format: Article
• Language: English
• Subjects: Animals; Antibodies, Viral - biosynthesis; Antibodies, Viral - blood; Biological and medical sciences; Cattle; Double-Blind Method; Drug Administration Schedule; Feces - virology; Female; Gastroenteritis - prevention & control; Gastroenteritis - virology; General aspects; Human infectious diseases. Experimental studies and models; Humans; Immunoglobulin A - blood; Immunoglobulin A - immunology; Infant; Infectious diseases; Male; Medical sciences; Reassortant Viruses - immunology; Rotavirus - immunology; Rotavirus Infections - immunology; Rotavirus Infections - prevention & control; Rotavirus Vaccines - adverse effects; Rotavirus Vaccines - immunology; Serotyping; Vaccines, Attenuated - immunology
• ISSN: 0022-3476; 1097-6833
• DOI: 10.1016/j.jpeds.2003.10.054

To investigate safety, efficacy, and immunogenicity of live quadrivalent rotavirus vaccine (QRV) containing human-bovine (WC3) reassortant rotavirus serotypes G1, G2, G3, and P1a. This was a randomized, double-blinded, placebo-controlled trial. During 1993 to 1994, at 10 US study sites, 439 healthy infants ∼2 to 6 months of age, were enrolled to receive 3 doses of oral QRV or placebo at approximately 8-week intervals. The vaccine was generally well tolerated; no serious vaccine-related adverse experiences were reported. Risk differences and 95% confidence intervals suggested no differences between vaccine and placebo recipients in the incidences of fever, irritability, vomiting, or diarrhea during the 14 days after any dose. QRV was 74.6% efficacious (95% CI: 49.5%, 88.3%) in preventing rotavirus acute gastroenteritis (AGE), regardless of severity and 100% efficacious (95% CI: 43.5%, 100%) in preventing severe rotavirus AGE through one rotavirus season. Serotype G1 was identified in most infants with rotavirus AGE. A ≥3-fold rise in serum neutralizing antibody to G1 was observed in 57% (45/79) of vaccinees. A ≥3-fold rise in serum anti-rotavirus IgA and fecal anti-rotavirus IgA was observed in 88% (162/185) and 65% (104/159) of vaccinees, respectively. QRV was generally well tolerated, immungenic, and highly effective against rotavirus gastroenteritis.